Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Auricular Vagus Nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: from 15 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Several treatment strategies, including surgical ones, are proposed but they are sometimes insufficient because endometriosis-related pain is frequently accompanied by sensitization. Endometriosis surgery, when indicated, is therefore changeably effective, even though the lesions have been completely resected. Patients therefore consult Pain Units seeking for the effective treatment as the pain persist even after surgical management of endometriosis. Vagus nerve stimulation is a non-invasive technique that includes an anti-inflammatory effect and a modulation of neurotransmitter production (adrenaline, norepinephrine; serotonin, acetylcholine). Yuan and Silberstein published a general review on the technique. Migraine and depression are one of the selected indications. In addition, Napadow et al. published favourable results in a short series of patients with chronic pelvic pain. The Investigators of this study have treated some patients with this technique with a result deemed satisfactory which leads to propose a randomized study to confirm this impression.
Interventions
- Device Transcutaneous Auricular Vagus Nerve Stimulation
Transcutaneous Auricular Vagus Nerve Stimulation has an eartip connected to an external stimulator. The device used in this study is the TENS Eco Plus commercialized by Schwa Medico and European Compliance (CE) marked. The electrode is positioned in the cymba concha of the left ear.
Primary outcome measures
- Change of symptoms related to the pelvic pain [Time frame: 3 months after enrolment]
Secondary outcome measures (9)
- Efficacy on pain [Time frame: Day 1 and 3 months after enrolment]
- Efficacy on severity of patient's symptoms [Time frame: Day 1 and 3 months after enrolment]
- Efficacy on quality of life [Time frame: Day 1 and 3 months after enrolment]
- Efficacy on quality of life [Time frame: Day 1 and 3 months after enrolment]
- Efficacy on Anxiety [Time frame: Day 1 and 3 months after enrolment]
- Efficacy on gynecological and pelvic pain symptoms [Time frame: Day 1 and 3 months after enrolment]
- Efficacy on gynecological and pelvic pain symptoms [Time frame: D1 and 3 months after enrolment]
- General efficacy of the device Transcutaneous Electronic Neuro Stimulation TENS Eco Plus [Time frame: 3 months after enrolment]
- Collection of possible side effects [Time frame: 3 months after Enrolement]
Eligibility criteria
Inclusion criteria
- Women aged >= 15 years
- With chronic pelvic pain and/ or dysmenorrhoea and/ or dyspareunia
- Who has been cared for by a gynecologist in one of the institutions participating in the study
- Diagnosed with endometriosis
- Having signed an informed written consent
- Affiliated to a health insurance scheme
Exclusion criteria
- contraindication to the use of transcutaneous auricular vagus nerve stimulation (cardiac pathology, asthmatic patient)
- pregnant or breastfeeding women
- patient undergoing in vitro fertilization
- associated pathology requiring long-term analgesic treatment
- patient with atria trans vagal neurostimulation in the 12 months prior to inclusion
- patient deprived of liberty or under guardianship
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hopital Foch — Suresnes
Identifiers
NCT: NCT04177511 · 2019-0057